Phenobarbital Dispensed Instead of Phentermine

JULY 01, 2004
Larry M. Simonsmeier, JD, RPh

Issue of the Case:

In this month's case, the Georgia Court of Appeals was presented with the often-asked question of whether a pharmacist who made a dispensing error could be held negligent if there was no proof that he caused the injury. More particularly, the issue centered on whether the court could withhold evidence of the pharmacist's misconduct for a later phase of the trial, and first require the jury to determine that the error even caused the harm.

Facts of the Case:

The plaintiff began taking fenfluramine and phentermine in 1997 to treat obesity. Approximately 3 months after beginning the therapy, the dispensing pharmacist erroneously filled the phentermine prescription with 30- mg phenobarbital tablets. Over the next several days, the plaintiff took 4 tablets of phenobarbital. She began to complain of fatigue, dizziness, headaches, lethargy, emotional instability, and nightmares.

Later the plaintiff "blacked out" while taking a bath. She called a pharmacy (not the dispensing pharmacy) and described the medication she had taken and her subsequent symptoms. The plaintiff's conversation with the pharmacist led her to believe that she had ingested phenobarbital. She called her husband, who rushed home and took her to an urgent care center.

The plaintiff was diagnosed with an adverse reaction to the drug. She was given intravenous fluids and activated charcoal, even though the level of phenobarbital in her blood was described as "barely detectable. Certainly not toxic."

The plaintiff later returned to the urgent care center, complaining that her right leg had become swollen and knotty and that she was having difficulty urinating. Although there was some disagreement among the experts, it was generally concluded that the problems in her leg were not caused by the phenobarbital, but were probably related to the varicose veins she suffered during pregnancy.

The defense also presented evidence that the plaintiff had a history of urinary tract infections and had sought treatment on at least 2 occasions prior to ingesting the phenobarbital. Furthermore, in response to her claims of fatigue and lethargy, the defense elicited testimony that she was up in the middle of the night giving bottles to her twin infants. Her husband worked 60 hours a week, and he stated that she had to take care of their 3 children and was often exhausted.

The Court's Ruling:

The trial judge ruled, as a matter of law, that the pharmacist and the pharmacy had breached their duty of care when the wrong drug was dispensed. Thus, there was no need to litigate the issue of negligence, but the question of causation and damages remained. The court split the issues and first asked the jury to determine whether the negligent act was the direct cause of the plaintiff's complaints. The jury found no causation and ruled in favor of the defendants. The plaintiff appealed, claiming that it was a mistake for the court to separate the issues. The appellate court affirmed the jury verdict.

The Court's Reasoning:

Appellate courts prefer not to separate a case into different phases, but wide discretion is given to the trial court on how to handle the situation. In this case, there was evidence that the dispensing pharmacist had a prior disciplinary action, but the court recognized that this fact might have improperly influenced the jury in determining causation. Instead, such evidence would be admissible only in the punitive damages phase of the trial, if the case went that far.

Additionally, the trial court ordered that the testimony of the plaintiff's expert witness, another pharmacist, regarding the applicable standard of care also would be admissible only in a later phase, because the question of standard of care was not at issue during the causation phase of the trial.

The court's instructions to the jury may be helpful in understanding why the court split the decision-making process: "Ladies and Gentlemen: In any negligence case, there are generally four elements that generally must be proven?One is a duty owed by the defendant to the plaintiff; number two would be a breach of that duty; three would be what is known as proximate cause or a causal relationship from the duty and the breach; and the fourth element would be damages. In this case, the first two issues have already been resolved . . . in favor of the plaintiff. So the only issues left for your consideration would be whether there is some causal connection between the defendant's conduct and the resulting injury, and whether there is some loss or damage."

Larry M. Simonsmeier is Emeritus Professor of Pharmacy Law at Washington State University College of Pharmacy.